NCT07022678 · Children's Oncology Group
Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
What this study is about
This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables.
View original scientific description
This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.
Interventions
OTHER
Best Practice
Given standard chemotherapy
PROCEDURE
Biospecimen Collection
Undergo saliva sample collection
DRUG
Cytarabine
Given IV
OTHER
Electronic Health Record Review
Ancillary studies
DRUG
Placebo Administration
Given intraorally
OTHER
Xylitol-containing Oral Wipe
Given intraorally
Primary outcome measures
Number of bloodstream infections (BSI) from oral flora
Time frame: Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study
Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient must be ≥ 1 year to ≤ 25 years old at enrollment.
- Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria.
- Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must:
- Contain IV cytarabine (liposomal formulations allowed), and
- The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles. Note: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted.
- Minimum of one visible or erupted tooth.
- Agree to avoid xylitol containing gum or toothpaste during intervention period.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion criteria
- Patients with Down syndrome-associated AML.
- Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.
- Patients with known history of allergy to xylitol.
- Patients with known history of allergy to grapes or grape flavoring.
- Patients who are actively being treated for an oral organism related blood stream infection.
- Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Madera, California
- Oakland, California
- Denver, Colorado
- Wilmington, Delaware
- Jacksonville, Florida
- Orlando, Florida
- Pensacola, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Des Moines, Iowa
And 23 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 25, 2026 · Source of record for eligibility and locations